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NCT Number: NCT01379313

The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

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Key information

About this study

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective gynecologic laparoscopic surgery
  • the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes

Exclusion criteria

  • ASA (American society of anesthesiologists) classification of the subjects more than III.
  • Age under 20, or more than 65 years.
  • Past history of pneumothorax, COPD, asthma.
  • Patients with ischemic heart disease, valvular heart disease.

Treatment and study plan

conventional I:E ratio

Procedure

conventional I:E ratio of 1:2 is applied.

1:1 ratio

Procedure

I:E ratio of 1:1 is applied.

2:1 group

Procedure

Inverse I:E ratio of 2:1 is applied.

external PEEP

Procedure

external positive end-expiratory pressure of 5 cmH2O is applied.

Primary outcomes

  1. arterial CO2 partial pressure

    Time frame: 10 minutes after induction of general anesthesia

    arteial CO2 partial pressure

  2. arterial CO2 partial pressure

    Time frame: 30 minutes after start of pneumoperitoneum

    arteial CO2 partial pressure

  3. arterial CO2 partial pressure

    Time frame: 60 minutes after start of pneumoperitoneum

    arteial CO2 partial pressure

Secondary outcomes

  1. arterial O2 partial pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    arterial O2 partial pressure

  2. Mean airway pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    Mean airway pressure

  3. tidal volume (setting)

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    tidal volume (setting)

  4. hemodynamic parameters

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    systolic/ diastolic blood pressure, heart rate, mean blood pressure

  5. end-tidal CO2 partial pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    end-tidal CO2 partial pressure

  6. respiratory compliance

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    Dynamic compliance, Static compliance

  7. Dead space

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    physiologic dead space / tidal volume (VD/VT)

  8. work of breathing

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    work of breathing

  9. peak inspiratory pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    peak inspiratory pressure

  10. plateau pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    plateau pressure

  11. positive end-expiratory pressure

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    positive end-expiratory pressure

  12. tidal volume (exhaled)

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    tidal volume (exhaled)

  13. minute ventilation

    Time frame: 10 min after induction, 30 and 60 min after start of pneumoperitoneum

    minute ventilation

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 23, 2011
Registry last updated
Oct 1, 2012

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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